ISO IDMP Standards

The set of fife ISO international standards has been developed by the ISO in response to a worldwide demand for internationally harmonised specifications for identification and description of medicinal products.

IDMP provides the basis for the unique identification of medicinal products, which facilitates the activities of medicines regulatory agencies worldwide by jurisdiction for a variety of regulatory activities (development, registration and life cycle management of medicinal products, pharmacovigilance, and risk management). They can also be applied to Investigational Medicinal Products.

Messaging specifications are included as an integral part of the IDMP Standards. They describe and protect the integrity of the interactions for the submission of regulated medicinal product information in the context of the unique product identification; they include acknowledgement of receipt including the validation of transmitted information. Health Level Seven (HL7) Message Exchange are normative within the IDMP Standards.

IDMP Standards are completed with Implementation Guides which are currently in development (2015), as well as with Technical Specifications (TS) 16791 (provides guidance for the identification of medicinal products by using intenational supply chain Standards, securing traceability, safe supply chain and other market requirements) and Technical Requirements (TR) 14872 (Requirements for the implementation of the Standards for the identification of medicinal products for the exchange of regulated medicinal product Information), the latter being in development.

Implications for Marketing Authorisation Holders (MAHs)

In order to submit the data all branches of a company should share a common language, from pharmacovigilance to product supply to comply with the controlled vocabulary dedicated.
The structured substance information, and controlled vocabularies for pharmaceutical dose forms, units of presentation, routes of administration, and packaging will be challenging to integrate.
Furthermore the terminology needs to be aligned throughout the company.

Regulated information on substances (ISO 11238)
ISO 11238 defines substances by their main, general characteristics and Specified Substances (which are more granular, specific descriptions of a substance, e.g. including manufaturing information, purity, grade). Substances can have different roles in medicinal products (e.g. active, adjuvant). They are identified via their molecular weight, structure and their unique Identification Number (ID).

SPOR

(as of 23.03.2018, Ursula Tschorn, IDMP SPOR Industry Change Liaison)

SPOR is short for Substances Products Organisations and Referentials in the IDMP projects of the EMA. SPOR data services will act as the vehicle for implementation of ISO IDMP standards in the regulatory and the e-health world.

SPOR data services

SPOR is aimed at delivering quality data services on Substances, Products, Organisations and Referentials to power EU regulatory activities.

Four projects have been established

Four projects have been established at the EMA to implement services that centralise management of each of the domains of master data. The four projects are collectively known as SPOR data services and the single once are abbreviated with SMS, PMS, OMS and RMS.

SPOR Data Services

Implementation of the four projects

The implementation of the four projects will be phased.

All proposals relating to implementation of the projects on Substances, Products, Organisation and Referentials have been and will continue to be consulted on widely with regulators and industry representatives.

IDMP with its referentials applies to both domains, Human and Veterinary

In parallel, EMA is implementing the messaging standards developed by Health Level Seven (HL7), which define a format for the electronic exchange of data that is compliant with the ISO IDMP technical specifications.

Use of SPOR in regulatory activities

Adoption of IDMP operating models will facilitate the implementation of consistent, centrally-maintained, ISO IDMP-compliant data, which will feed regulatory activity across the product lifecycle.

Benefits

Standardised data alone is not sufficient to achieve benefits. The benefits will be realised incrementally:

New ways of accessing SPOR data

Draft API specifications have been shared with SPOR Task Force; final API specifications are expected to be published in August

For RMS, backward compatibility will be maintained with EUTCT for NCAs who use EUTCT

*An API is a mechanism to allow your IT systems to exchange information automatically with RMS and OMS

Download SPOR API Documentation
(Udated 9.1.2018)

A new edition (version 1.14 published 09.01.2018) of the SPOR API documentation (API schemas, OMS & RMS message formats and HL7) is accessible for interested parties for a free download in this website:

The latest version of the API specification incorporates the following additional information:

A description of how an implementing system must retain rowid elements in the creation, and later management, of change requests in RMS.

A description on the fields that have to be conditionally provided when dealing with both OMS and RMS change requests depending on the status and the data of such requests.

An explanation on how OMS retains compatibility for searching elements based on identifiers, even after they have been merged, and how the current identifier, of an element, is highlighted in the response data.

A description on what kind of change requests can be filed in OMS depending on the status of the referred organisation and/or location.

The API specification covers both RMS and OMS. This has been taken through consultation during April to July 2016 and the feedback has been incorporated in the specification (consultation is now closed).

Please note that in the SPOR API specification, the services are set out in Section 6 and those that are OMS-specific are marked “O”, RMS-specific are marked “R”, and services shared by both RMS and OMS are marked as “RO”.

The documents have been shared with the SPOR Task Force and UAT testers.

EMA Data Stewards

EMA will take over the function of a data steward to maintain and coordinate the SPOR data.

A specialised team of EMA staff that will manage data on behalf of stakeholders and provide user support

Validate access requests to SPOR services

Directly involved in maintaining the quality of the data:
Profiling the data (assessing quality of data)
Various data anomalies (different formats of the data e.g. telephone number) can be identified / monitored and data correction can be initiated
Reports generated using this cleansed data will be more reliable

Take action on change requests for new/amended Referential Lists/Terms and Organisation data

Organisations Management Services OMS Operating Model

Key Industry engagement activities

Industry is now asked to start with mapping activities from their local data to IDMP SPOR referentials

Industry Change Liaisons will provide a continuous channel for information and training throughout the year

In addition, a number of specific events are planned that will be open to all Industry stakeholders

In summary

SPOR data services will act as the vehicle for implementation of ISO IDMP standards

SPOR data services will enable the realisation of benefits at all stages of the product lifecycle due to future integration of regulatory processes with SPOR’s standardised data and central data management services

Implementation of RMS and OMS is the first step in a phased approach to roll-out of SPOR and of other Programmes dependent on SPOR data

In order to be ready for the future changes brought about by IDMP and by integration with other Programmes, Industry should prepare now to ensure they have the foundations in place through alignment with RMS and OMS